Phase I/II studies to evaluate safety and immunogenicity of a recombinant gp350 Epstein-Barr virus vaccine in healthy adults

Vaccine. 2007 Jun 11;25(24):4697-705. doi: 10.1016/j.vaccine.2007.04.008. Epub 2007 Apr 18.


Two double-blind randomised controlled studies (phase I and I/II) were performed to assess for the first time the safety and immunogenicity of a recombinant subunit gp350 Epstein-Barr virus (EBV) vaccine in 148 healthy adult volunteers. All candidate vaccine formulations had a good safety profile and were well tolerated, with the incidence of solicited and unsolicited symptoms within a clinically acceptable range. One serious adverse event was reported in the phase I trial which was considered to be of suspected relationship to vaccination. The gp350 vaccine formulations were immunogenic and induced gp350-specific antibody responses (including neutralising antibodies).

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / blood
  • Antigens, Viral / immunology*
  • Double-Blind Method
  • Enzyme-Linked Immunosorbent Assay
  • Epstein-Barr Virus Infections / prevention & control*
  • Female
  • Herpesvirus 4, Human / immunology*
  • Herpesvirus Vaccines / adverse effects*
  • Herpesvirus Vaccines / immunology*
  • Humans
  • Male
  • Neutralization Tests
  • Vaccines, Subunit / adverse effects
  • Vaccines, Subunit / immunology
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / immunology
  • Viral Matrix Proteins / immunology*


  • Antibodies, Viral
  • Antigens, Viral
  • EBV-associated membrane antigen, Epstein-Barr virus
  • Herpesvirus Vaccines
  • Vaccines, Subunit
  • Vaccines, Synthetic
  • Viral Matrix Proteins